Catalog Number 8698G |
Device Problem
Reaction (1514)
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Patient Problems
Reaction (2414); Treatment with medication(s) (2571)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The actual device batch number associated with this event is not known.Two possible batch numbers are reported as follows: (b)(4).In addition, a review of the batch manufacturing records for the possible batch number (b)(4) was conducted and the batch met all finished goods release criteria.
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Manufacturer Narrative
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Conclusion: representative samples from the same lot number as the actual device were returned for evaluation of the packaging.The overwrap was evaluated.There does not appear to be any issues with the packaging of the product to cause the reported event.
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Event Description
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It was reported that a patient underwent a skin closure procedure on an unknown date and suture was used for two layer suturing.The patient experienced redness and burning.The patient had topical steroids applied to the area.Additional information was requested.
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Manufacturer Narrative
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(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.The actual device batch number associated with this event is not known.Two possible batch numbers are reported as follows: (b)(4).In addition, a review of the batch manufacturing records for the possible batch number (b)(4) was conducted and the batch met all finished goods release criteria.
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Search Alerts/Recalls
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